Implanting method

ABSTRACT

A method for introducing a two-piece implant into a living being. A tubular organ such as a vas deferens is divided into a pair of separate portions having free ends adjacent each other. The implant has a pair of parts which are separately introduced into the lumens of the separate portions of the tubular organ while the parts of the implant remain accessible at the free ends of these separate portions of the tubular organ. These parts which are thus accessible are then joined together to render the implant operative without excessive stretching of the tubular organ so that excessive slack is not produced therein. The tubular organ may be a vas deferens while the implant is a vas valve capable of reversively blocking flow in the vas deferens and having the separate parts one of which is constituted by a tubular component and the other of which is constituted by the remainder of the vas valve, these parts being united after being introduced into the lumens to provide the assembled vas valve.

United States Patent [191 Bucalo IMPLANTING METHOD [75] Inventor: LouisBucalo, Holbrook, N.Y.

[73] Assignee: Investors In Ventures, Inc., New

York, NY.

[22] Filed: Feb. 12, 1973 [21] Appl. No.: 332,019

[52] U.S. Cl 128/334 C [51] Int. Cl A61b 17/11 [58] Field of Search..128/1 R, 303 R, 334 R; 334 C, 128/348 [56] References Cited UNITEDSTATES PATENTS 2,638,901 5/1953 Sugarbaker 128/334C 3,030,953 4/1962Koehn 128/214.4

3,704,704 12/1972 Gonzales 128/1 R Primary Examiner-Da1ton L. TruluckAttorney, Agent, or FirmSteinberg & Blake [451 Apr. 15, 1975 [57]ABSTRACT A method for introducing a two-piece implant into a livingbeing. A tubular organ such as a vas deferens is divided into a pair ofseparate portions having free ends adjacent each other. The implant hasa pair of parts which are separately introduced into the lumens of theseparate portions of the tubular organ while the parts of the implantremain accessible at the free ends of these separate portions of thetubular organ. These parts which are thus accessible are then joinedtogether to render the implant operative without excessive stretching ofthe tubular organ so that excessive slackis not produced therein. Thetubular organ may be a vas deferens while the implant is a vas valvecapable of reversively blocking flow in the vas deferens and having theseparate parts one of which is constituted by a tubular component andthe other of which is constituted by the remainder of the vas valve,these parts being united after being introduced into the lumens toprovide the assembled vas valve.

2 Claims, 10 Drawing Figures 52 I54 ,2 /0\ ,8 1.. i 1* i 56 T ///,l(//1/1/ E X/V/ /l// IMPLANTING METHOD BACKGROUND OF THE INVENTION Thepresent invention relates to methods for introducing implants for livingbeings.

In particular, the present invention relates to methods for introducingimplants which are designed to be received in the lumens of tubularorgans.

When an implant such as a vas valve is to be introduced into the lumenof a tubular organ such as a vas deferens, it is customary to divide thetubular organ such as the vas deferens into a pair of separate portionswhich have free ends adjacent to each other. The surgeon will thenintroduce the implant, such as a vas valve, first into the lumen of oneof the separate portions of the tubular organ and then into the lumen ofthe other of the separate portions of the tubular organ. Because theparts of the implant which are respectively received in these lumens ofthe separate portions of the tubular organ are relatively long, it isnecessary for the surgeon to stretch the tubular organ and distend it toan undesirable extent in order to be able to effectively introduce theimplant into the lumens of the separate portions of the tubular organ.The result of these procedures is that a considerable amount of slack isintroduced into the tubular organ resulting sometimes in prevention ofreestablishment of flow when an implant such as a valve is placed in itsopen position.

A further problem which is encountered with an implant which is in theform of a valve is that it is sometimes difficult for the physician toknow from the exterior ofthe valve when it is in its open position andwhen it is in its closed position.

In addition, when the implant is a valve, it sometimes happens that theopenings at the opposed free ends of the valve become blocked bysubstances situated in the lumen of the vas deferens or the like, sothat even when the valve is open to reestablish flow through the tubularorgan, such flow cannot be reliably established.

In this latter connection, it sometimes happens that even duringintroduction of the implant into the lumen, substances in the lumenitself flow into the interior of the implant blocking the interior ofthe implant and preventing flow therethrough in an desirable manner.

SUMMARY OF THE INVENTION It is accordingly a primary object of thepresent invention to provide an implant and implanting method which willavoid the above drawbacks.

In particular, it is an object of the present invention to provide animplant and implanting method which will avoid the necessity ofexcessive distension of the tubular organ during introduction of theimplant into the lumen thereof.

A more specific object of the present invention is to provide animplanting method involving a vas valve which can be introduced into atubular organ formed by a vas deferens in such a way that excessivedistension of the latter will not be required.

It is also an object of the present invention to provide an implantingmethod which enables a vas valve to be introduced into the vas deferensin a manner which will avoid blocking of the interior of the valve.

According to the method of the invention, the tubular organ which is toreceive the implant is cut through so as to form a pair of portionshaving free ends situated adjacent each other, and then a two-partimplant has its respective parts introduced separately into the lumensof the separate portions of the tubular organ with the two parts of theimplant accessible at the free ends of these separate portions. Theseseparate parts of the implant are then joined to each other so as torender the implant operative and so as to complete the assembly thereof,and through this expedient it becomes possible to introduce the implantwithout excessive distension of the tubular organ.

BRIEF DESCRIPTION OF DRAWINGS The invention is illustrated by way ofexample in the accompanying drawings which form part of this applicationand in which:

FIG. 1 is a longitudinal sectional elevation schematically illustratinga vas deferens with an implant of the invention situated therein;

FIG. 2 is an end view of the vas valve of FIG. 1 as seen from the rightof FIG. 1;

FIG. 3 is a fragmentary sectional elevation illustrating the connectingmeans carried by the separate components of the vas valve for connectingthem to each other;

FIG. 4 is a fragmentary side elevation of one end region of the vasvalve, the other end region having the same construction;

FIG. 5 is a transverse sectional elevation of the structure of FIG. 4taken along line 55 of FIG. 4 in the direction of the arrows;

FIG. 6 is a schematic illustration of the method of the presentinvention for introducing an implant into a tubular organ;

FIG. 7 shows in elevation a mandrel to be used with one of thecomponents of FIG. 1;

FIG. 8 is an illustration of another mandrel to be used with the otherof the components of the vas valve of FIG. 1;

FIG. 9 is a fragmentary side elevation of one end of the vas valve ofFIG. 1 showing a further addition thereto; and

FIG. 10 is a transverse section of the structure of FIG. 9 taken alongline l0-10 of FIG. 9 in the direction of the arrows.

DESCRIPTION OF PREFERRED EMBODIMENTS Referring to FIG. 1, the implant 10of the invention is in the form of a vas valve in the illustratedexample. This valve includes a pair of parts 12 and 14. The part 12 isin the form of an elongated tube made of any suitable material which iscompatible with the body, while the part 14 includes therest of the vasvalve. Thus, the part 14 includes the valve housing 16 carrying in itsinterior the rotary valve member whose stem is connected to the turnableelement 18 at the exterior of the valve. This element 18 is turned forthe purpose of opening and closing the valve. In addition, the part 14includes the tubular element 20 which is integral with and extends tothe right from the housing 16, as illustrated in FIG. 1. This tubularpart 20 may be located at the teste side of the valve while the part 12may be located at the urethral side.

The tubular part 12 is formed at the region of its free end which isdistant from the part 14 with a longitudinally extending slot 22extending completely across the tubular part 12 inwardly from the leftfree end thereof, as viewed in FIG. 1, through the distance indicated inFIG. 1. In the same way, the tubular part 20 is formed with an elongatedslit 24 extending completely across the part 20 and inwardly from theright free end thereof through a distance such as that indicated at theright in FIG. 1.

In addition, the part 12 terminates at its right end in a barrier flange26 formed, as shown in FIG. 2, with four peripheral Vnotches 28displaced by 90 with respect to each other about the periphery of theflange 26 so as to promote the ingrowth of tissue into these notches andthus provide a secure lodging of the part 12 in the vas deferens whichforms the tubular organ in the illustrated example. In addition, theflange 26 is formed with a series of openings 28 through which tissuemay grow.

A means is provided for fastening the parts 12 and 14 to each otherafter they are respectively introduced into the lumens of the separateportions of vas deferens which are illustrated in FIG. 1. Thus, beforethe implant is situated in the tubular organ, this organ is transverselycut through so as to be divided into a pair of separate portions. Thusit will be seen that the vas deferens illustrated in FIG. 1 includes theelongated left portion 30 and the elongated right portion 32, theseportions respectively terminating in the free ends 34 and 36 which areadjacent each other. As may be seen from FIG. 6., after the vas deferensillustrated has been cut through, its separate portions 30 and 32 needonly be deflected to an extremely small extent so as to be capable ofreceiving the implant of the invention. The part 30 which is angularlypositioned approximately as shown in FIG. 6 will separately receive thetubular part 12 of the vas valve, this part being first covered at itsexterior with a filamentary material such as gold wire 38. This wire maybe wound around the exterior of the tubular part 12 and may also takethe form of a suitable braid. Thus, by way of the use of thisfilamentary material it is possible to promote the ingrowth of tissueinto intimate contact with the exterior surface of the tubular part 12,so as to greatly reduce the possibility of travel of sperm along theexterior of the tubular component 12.

In the same way, with the separate portion 32 of the vas deferenssituated somewhat illustrated in FIG. 6, it is possible for the surgeonto introduce the other part 14 into the lumen of the separate portion32. This part 14 also carries at the exterior of the tubular extensionthe filamentary material 40 in the form of gold wire or braid whichcovers the exterior surface of the tubular portion 20, and it will benoted that this material is extended all the way up to the part of thehousing 16 which engages the vas deferens, and the braid or wire 38 alsoextends all the way up to the part of the flange 26 which engages thevas deferens. Thus the ingrowth of tissue will also be promoted intointimate contact with the exterior surface of the part 20 and the partof the housing 16 adjacent to the part 20 in order to reduce thepossibility of travel of sperm along the exterior of the part 14.

These parts 12 and 14 of the implant carry a means 42 forinterconnecting these parts with each other after they have beenintroduced into the lumens of the separate portions and 32 of thetubular organ. This connecting means 42 is shown in detail in FIG. 3.Thus in accordance with the illustrated example the tubular part 12 hasat the region of the flange 26 a female component 44 which is hollow andtapered at its interior, while the part 14 has a mating male component46 which has at its exterior a taper which matches that of the interiorof the female component 44. Thus, with this construction after the twoparts of the valve are respectively received in the lumens of theseparate portions 30 and 32, the male component 46 and the femalecomponent 44 of the connecting means 42 are joined together with themale part 46 received with a tight wedge fit in the female part 44, sothat in this way the valve is rendered operative.

As a result of this feature the extent to which the tubular organ mustbe distended is greatly reduced so that there is very little if anyslack which will produce undesired curvature of the tubular organpreventing in some cases the desired reestablishment of flow through thetubular organ. Thus, by dividing the implant into two parts which arejoined to each other after the parts are respectively received in thelumens of the separate portions of the tubular organ, it is possible tojoin these parts together in such a way that the extent to which thetubular organ must be stretched and displaced from its initial locationis very greatly reduced.

According to a further feature of the invention, prior to introducingthe part 12 into the lumen of the portion 30 of the vas deferens, themandrel 48 shown in FIG. 7 is situated in the interior of and fills thelongitudinal bore of the part 12 so that this bore will not becomeblocked by or receive any of the material within the portion 30 of thevas deferens. In the same way a second mandrel 50 is situated in andcompletely fills the tubular part 20 at the bore of the latter so thatthis bore cannot become blocked during introduction of the part 14 intothe lumen of the separate portion 32 of the vas deferens. For thispurpose it is to be noted that the part 18 is turned so as to situatethe valve in its open position, and the mandrel 50 is long enough toextend through the bore of the rotary valve member as well as throughthe male part 46 of the connecting means and of course through theentire length of the tube 20 all the way up to the right end of thelatter.

In this connection it is to be noted that after completion of theimplanting procedures even if it should happen that the free ends of thetubular part 12 and 20 which are distant from each other become blocked,it will nevertheless be possible for the semen and other fluids to enterinto the bores of the tubular parts 12 and 20 through the slots 22.Thus, after the implant has been introduced into the tubular organ, thevalve will, after a certain period of time, be turned to its closedposition. For this purpose the rotary part 18 carries a cross pin 52received in suitable slots of a rotary wrench 54 shown in phantom linesin FIG. 1. The part 18 fixedly carries a springy detent 56 capable ofbeing received either in the recess 58, at the periphery of an upperflange of the housing 16, when the valve is in its open position asillustrated, or in a detent recess 60 displaced from the recess 58. Whenthe springy detent 56 is in the recess 60 the valve is closed. Thus byproviding these detent recesses and the springy detent member 56 it ispossible for the operator to reliably locate the valve either in itsopen or closed position without any difficulty.

It will be noted from FIGS. 7 and 8 that the mandrels 48 and 50 arerespectively provided with handles 62 and 64. After the part 12 has beensituated within the lumen of the separate portion 30 of the vasdeferens, the mandrel 48 is removed, and the handle 62 is provided tofacilitate the introduction and removal of the mandrel 48 from thetubular part 12. In the same way, after the part 14 has been received inthe lumen of the separate portion 32 of the vas deferens, the mandrel 50is removed, and the handle 64 facilitates the introduction and removalof the mandrel 50 from the part 14.

It is to be noted that the slots 22 and 24 may be replaced by a seriesof lateral openings 66 illustrated in FIGS. 4 and 5. Thus, instead oflongitudinally extending slots as illustrated in FIG. 1, it is possibleto provide the free ends of the valve each with a plurality of openings66 as shown in FIGS. 4 and 5 at the free end of the tubular part 20, andthus with this construction also if it should happen that the free endof the tubular extension becomes blocked nevertheless it will bepossible for fluid to enter through the lateral openings 66. Thus, thisconstruction of FIGS. 4 and 5 is also included at the left end portionof the part 12 instead of the slot 22, if desired. Therefore, eitherwith the slots 22 and 24 or with the lateral openings 66 it is possiblewhen the valve is placed in its open position to reestablish flowthrough the tubular organ in a highly reliable manner even if it shouldhappen that the free ends of the tubular organ become blocked.

Thus, the vas valve will initially remain in its open position until asufficient time has elapsed for the implant to become properly lodged inthe tubular organ with ingrowth of tissue occurring and with no possiblebuild up of pressure within the tubular organ. Then the valve may beplaced in its closed position so as to block the flow, and thus reliablyprevent conception. In this connection it is to be noted that theingrowth of tissue at the filamentary material at the exterior of thevalve greatly cuts down any possibility of travel of sperm along theexterior of the valve. This prevention of travel of sperm along theexterior of the valve is greatly enhanced by the presence of the barrier26. However, if it should be desired at any future time to reestablishthe flow of fluid through the vas deferens, the valve can be returned toits open position, and then by reason of the slots 22 and 24 or theopenings 66 a reliable reestablishment of flow is assured. Furthermore,because of the minimal distension of the tubular organ during theintroduction of the implant, according to the method of the invention,utilizing a two-part implant which has its parts connected to each otherafter they are received in the tubular organ, as described above, thereis no possibility of formation of loops or other undesirableconfigurations in the tubular organ resulting from undesirable slacktherein, so that in this way also a reestablishment of flow is assuredand the possibility of undesirable growths or the like which couldresult from such slack is also reliably avoided.

In order to further prevent blocking of the interior of the vas valve.further measures are taken in accordance with further features of theinvention.

Thus, upon cutting through the vas to provide the separated portions 30and 32 shown in FIG. 6, it will be found that lumen is covered with alayer of mucosa. In accordance with a further feature of the presentinvention a suitable reamer which is not illustrated is introduced intothe lumen of the portion 30 of the vas so as to remove from the innersurface the lining of mucosa at least through a length equal to thatwhich will subsequently be occupied by the left portion of the valve asillustrated in FIG. I. The same operations are then performed with theright portion 32 of the vas deferens so that in the latter also theinner lining of mucosa is removed at least through a length sufficientto accommodate the right portion of the valve as illustrated in FIG. 1.Thus, through this expedient of reaming out the mucosa linings along thelumen portions where the vas valve is to be accommodated there is aconsiderable reduction of possibility of blocking the valve passagesduring introduction of the valve into the lumen of the vas.

Furthermore, as is illustrated in FIGS. 4 and 5, the exterior surfacesof the valve at the region of its opposed ends is provided with acoating of plastic 70. Thus, FIGS. 4 and 5 illustrate that embodimentwhere the opposed ends are provided with the lateral openings 66 asdescribed above, but the plastic coating of FIGS. 4 and 5 can also beutilized with the embodiment of FIG. 1 where the opposed ends of thevalve are provided with the slots 22 and 24. In the case of FIGS. 4 and5 the openings 66 are not covered by the plastic layer 70, and of coursewith the embodiment of FIG. 1 the slots 22 and 24 also would not becovered by the plastic coating. This plastic coating 70 which isdeposited in any suitable way on the exterior surface of the valve atits opposed end regions as illustrated in FIGS. 4 and 5 has the propertyof bonding itself intimately to the exterior surface of the valve sothat it will remain securely connected thereto, and in addition theplastic coating will prevent the vas from adhering at its lumen to theexterior surface of the valve at the end regions thereof which areprovided with the plastic coating 70. This plastic coating may be madeof any plastic which will not adhere to the inner surface of the vasdeferens. For example Teflon may be used for the plastic layer 70 whichwill prevent the vas from adhering to the outer end regions of the valveso that in this way there is an assurance that the openings 66 willremain free and clear to function properly whenever it is desired toreestablish fluid flow. Of course the same results will be achieved whenthe plastic coating is provided with the embodiment of FIG. 1. WhileTeflon has been mentioned above, it is of course possible to use anyother plastic which is compatible with the human body and which has theproperty of preventing the vas from adhering to the surface of theplastic.

A further expedient for achieving results similar to those achieved withthe embodiment of FIGS. 4 and 5 is illustrated in FIGS. 9 and 10. Thus,referring to FIGS. 9 and 10 it will be seen that the end of the valvewhich has the slot 24 has deposited thereon elongated andcircumferential beads 72. These beads 72 are made of a metal which isdifferent from the metal used for the valve. The longitudinal andcircumferential beads 72 are deposited in any suitable way on theelongated free end portion of the valve which is provided with the slot24 shown in FIGS. 9 and 10, and of course the opposed elongated endregion of the valve which is provided with slot 22 is also provided withthese beads of metal 72. The beads of metal 72 are made of any metalwhich is different from the metal used for the valve. For example if theelongated end regions of the valve are made of gold, then the beads 72may be made of platinum or nickel.

Of course, this deposition of beads of a dissimilar metal on theexterior surface of the end regions of the valve can also be used withthe embodiment of FIGS. 4 and 5, in which case the beads will not closeany of the openings 66. It will be noted that the beads do not close theslots 22 or 24.

As a result of the presence of the dissimilar metals there is anautomatic generation of microvoltages which have the effect also ofpreventing adherence of the vas to the regions of the valve where thedissimilar metals are located. Therefore by depositing on the endregions of the valve beads 72 of a metal different from the metal onwhich the beads are deposited there is an automatic creation ofmicrovoltages which will reliably prevent adhering of the vas to the endregions of the valve. it is to be noted that the beads 72 are shown at aconsiderable distance from each other in FIGS. 9 and 10 for the sake ofclarity. Actually the network of longitudinal and circumferential beadswill be denser than illustrated in FIGS. 9 and 10.

Therefore, by way of these expedients it is possible on the one hand toprevent the vas from adhering to the end regions of the valve and on theother hand by reaming out the interior mucosa linings initial blockingof the valve during introduction of the latter into the lumen is alsoreliably prevented.

What is claimed is:

1. In a method for introducing an implant into a tubular organ of aliving being, the steps of cutting transversely through the tubularorgan to divide the latter into a pair of separate portions respectivelyhaving free ends located adjacent each other, introducing one part of animplant into the lumen of one of the separate portions of the tubularorgan through the free end of the latter while maintaining said one partof said implant accessible at the latter free end, introducing anotherpart of the implant into the lumen of the other of the separate portionsof the tubular organ through the free end of the latter whilemaintaining said other part of said implant accessible at the latterfree end, and then 10 joining the parts of the implant directly to eachother without any space therebetween, so that the entire implantis'introduced into the lumens of the separate portions of the tubularorgan without excessive stretching and displacement of the tubular organduring introduction of the implant into the latter, the'tubular organbeing a vas deferens and the implant being a valve, and including thesteps of removing inner mucosa linings from the lumens of the separateportions of the vas deferens prior to introduction of the valve partsinto the lumens so as to reduce the possibility of blocking valvepassages during introduction of the valve parts into the lumen.

2. In a method as recited in claim 1 and wherein the mucosa linings areremoved by reaming operations.

1. In a method for introducing an implant into a tubular organ of a living being, the steps of cutting transversely through the tubular organ to divide the latter into a pair of separate portions respectively having free ends located adjacent each other, introducing one part of an implant into the lumen of one of the separate portions of the tubular organ through the free end of the latter while maintaining said one part of said implant accessible at the latter free end, introducing another part of the implant into the lumen of the other of the separate portions of the tubular organ through the free end of the latter whilE maintaining said other part of said implant accessible at the latter free end, and then joining the parts of the implant directly to each other without any space therebetween, so that the entire implant is introduced into the lumens of the separate portions of the tubular organ without excessive stretching and displacement of the tubular organ during introduction of the implant into the latter, the tubular organ being a vas deferens and the implant being a valve, and including the steps of removing inner mucosa linings from the lumens of the separate portions of the vas deferens prior to introduction of the valve parts into the lumens so as to reduce the possibility of blocking valve passages during introduction of the valve parts into the lumen.
 2. In a method as recited in claim 1 and wherein the mucosa linings are removed by reaming operations. 